Heart valve regurgitation anchor and delivery tool

ABSTRACT

A heart valve anchor apparatus may include a body having a proximal portion and a distal portion. The body may include a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. In an unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to U.S.Provisional Patent Application Ser. No. 62/375,564, filed Aug. 16, 2016,the disclosure of which is incorporated herein by reference

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and/or using medical devices. More particularly, thepresent disclosure pertains to configurations of heart valveregurgitation anchors and delivery tools for heart valve regurgitationanchors.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, surgical and/or intravascular use. Some ofthese devices include guidewires, catheters, medical device deliverysystems (e.g., for stents, grafts, replacement valves, etc.), and thelike. These devices are manufactured by any one of a variety ofdifferent manufacturing methods and may be used according to any one ofa variety of methods. Of the known medical devices and methods, each hascertain advantages and disadvantages. There is an ongoing need toprovide alternative medical devices as well as alternative methods formanufacturing and/or using medical devices.

SUMMARY

In a first aspect, a heart valve anchor apparatus may comprise a bodyhaving a proximal portion, a proximal end, a distal portion, and adistal end, the body having a delivery configuration, an unstressedconfiguration, and a shortened configuration. The body may comprise afirst radially expandable portion at the proximal portion of the body, asecond radially expandable portion at the distal portion of the body,and a root portion extending from the first radially expandable portionto the second radially expandable portion, the root portion having anouter extent. The first radially expandable portion may be configured toself-expand to an outer extent greater than the outer extent of the rootportion when radially unconstrained. The second radially expandableportion may be configured to self-expand to an outer extent greater thanthe outer extent of the root portion when radially unconstrained. In theunstressed configuration, the body may define a longitudinal centerlinethat extends away from a plane tangent to the root portion.

In addition or alternatively, and in a second aspect, the body isadapted to be housed at least partially within a tissue penetratingdevice in the delivery configuration.

In addition or alternatively, and in a third aspect, the body is adaptedto engage tissue between the proximal portion and the distal portion inthe unstressed configuration and the shortened configuration, such thatone or more plications of tissue are formed between the proximal portionand the distal portion.

In addition or alternatively, and in a fourth aspect, the body isadapted to compress tissue between the proximal portion and the distalportion in the shortened configuration.

In addition or alternatively, and in a fifth aspect, the root portion isadapted to pass through tissue disposed between the proximal portion andthe distal portion.

In addition or alternatively, and in a sixth aspect, the body has anoverall length in the unstressed configuration and the overall length isreduced when the body is in the shortened configuration.

In addition or alternatively, and in a seventh aspect, the heart valveanchor apparatus may further comprise a suture element disposed throughthe body along the longitudinal centerline.

In addition or alternatively, and in an eighth aspect, the heart valveanchor apparatus may further comprise a needle, a suture element havinga proximal end attached to the needle, and an elongated sheath having adeployment head fixedly attached at a proximal end of the elongatedsheath. The suture element may pass distally into the deployment headand have a stop feature disposed within the deployment head. The bodymay be disposed at least partially within the elongated sheath.

In addition or alternatively, and in a ninth aspect, translation of theelongated sheath proximally relative to the body releases the body suchthat the body is free to assume the unstressed configuration.

In addition or alternatively, and in a tenth aspect, in the deliveryconfiguration, the first radially expandable portion is disposed withinthe elongated sheath and the second radially expandable portion isdisposed distal of the elongated sheath.

In addition or alternatively, and in an eleventh aspect, the stopfeature is disposed proximal of the first radially expandable portion.

In addition or alternatively, and in a twelfth aspect, the heart valveanchor apparatus may further comprise a tissue penetrating deviceincluding a lumen extending longitudinally therethrough, the body beingdisposed within the lumen in the delivery configuration, and a push roddisposed within the lumen adjacent to the body. Translation of the pushrod relative to the tissue penetrating device may release the body fromthe lumen. After release from the lumen, the body may assume theunstressed configuration.

In addition or alternatively, and in a thirteenth aspect, the heartvalve anchor further includes a suture element extending longitudinallythrough the body to a stop feature disposed opposite the push rod,wherein placing the suture element in tension while applying an opposingforce to the body with the push rod places the body into a shortenedconfiguration wherein the tissue is compressed between the firstradially expandable portion and the second radially expandable portion.

In addition or alternatively, and in a fourteenth aspect, a method ofdeploying a heart valve anchor apparatus may comprise:

inserting a tissue penetrating device into tissue forming a heart valveannulus such that a distal end of the tissue penetrating deviceprotrudes from the tissue, the tissue penetrating device having a heartvalve anchor apparatus disposed within a lumen of the tissue penetratingdevice in a delivery configuration, the heart valve anchor apparatuscomprising a body comprising a first radially expandable portion at aproximal portion of the body, a second radially expandable portion at adistal portion of the body, and a root portion extending from the firstradially expandable portion to the second radially expandable portion,the root portion having an outer extent, wherein the first radiallyexpandable portion is configured to self-expand to an outer extentgreater than the outer extent of the root portion when radiallyunconstrained, wherein the second radially expandable portion isconfigured to self-expand to an outer extent greater than the outerextent of the root portion when radially unconstrained;

actuating a handle element of the tissue penetrating device to push thesecond radially expandable portion out of the distal end of the tissuepenetrating device outside of the tissue; and

withdrawing the tissue penetrating device through the tissue, therebyreleasing the root portion within the tissue and the first radiallyexpandable portion outside of the tissue, such that the first radiallyexpandable portion and the second radially expandable portion bothengage the tissue disposed between them in an unstressed configuration;

wherein in the unstressed configuration, the body defines a longitudinalcenterline that extends away from a plane tangent to the root portion.

In addition or alternatively, and in a fifteenth aspect, the heart valveanchor apparatus further includes a suture element extendinglongitudinally through the body to a stop feature disposed distally ofthe second radially expandable portion, and the method further includesthe step of applying tension to a proximal portion of the suture elementwhile applying a distally-directed force to the proximal portion of thebody to place the body into a shortened configuration wherein the tissueis compressed between the first radially expandable portion and thesecond radially expandable portion.

In addition or alternatively, and in a sixteenth aspect, a method ofdeploying a heart valve anchor apparatus may comprise:

inserting a tissue penetrating device into tissue forming a heart valveannulus such that a proximal end of the tissue penetrating deviceprotrudes from the tissue, the tissue penetrating device having aproximal end of a suture element attached to a distal portion of thetissue penetrating device, the suture element of the tissue penetratingdevice passing into a deployment head fixedly attached at a proximal endof an elongated sheath, wherein at least a portion of a heart valveanchor apparatus is disposed within a lumen of the elongated sheath in adelivery configuration, the heart valve anchor apparatus comprising abody comprising a first radially expandable portion at a proximalportion of the body, a second radially expandable portion at a distalportion of the body, and a root portion extending from the firstradially expandable portion to the second radially expandable portion,the root portion having an outer extent, wherein the first radiallyexpandable portion is configured to self-expand to an outer extentgreater than the outer extent of the root portion when radiallyunconstrained, wherein the second radially expandable portion isconfigured to self-expand to an outer extent greater than the outerextent of the root portion when radially unconstrained, wherein in thedelivery configuration, the first radially expandable portion isdisposed within the elongated sheath and the second radially expandableportion is disposed distally of the elongated sheath;

pulling the tissue penetrating device away from the tissue such that thedeployment head passes through the tissue and the second radiallyexpandable portion is engaged against the tissue; and

pulling the elongated sheath away from the second radially expandableportion, thereby releasing the root portion within the tissue and thefirst radially expandable portion outside of the tissue, such that thefirst radially expandable portion and the second radially expandableportion both engage the tissue disposed between them in an unstressedconfiguration;

wherein in the unstressed configuration, the body defines a longitudinalcenterline that extends away from a plane tangent to the root portion.

In addition or alternatively, and in a seventeenth aspect, the sutureelement includes a stop feature disposed within the deployment head.After engaging the second radially expandable portion against thetissue, further pulling the tissue penetrating device away from thetissue engages the stop feature with a proximal end of the deploymenthead to pull the elongated sheath away from the second radiallyexpandable portion.

In addition or alternatively, and in an eighteenth aspect, the heartvalve anchor includes a suture element extending distally from thesecond radially expandable portion, and the method further includes thestep of applying tension to a distal portion of the suture element ofthe heart valve anchor while applying a proximally-directed force to thedistal portion of the body to place the body into a shortenedconfiguration wherein the tissue is compressed between the firstradially expandable portion and the second radially expandable portion.

In addition or alternatively, and in a nineteenth aspect, the sutureelement of the tissue penetrating device passes through elongated sheathand the body, and includes a stop feature disposed within the deploymenthead. Pulling the elongated sheath away from the second radiallyexpandable portion includes grasping the deployment head with a tool andpulling the elongated sheath away from the second radially expandableportion along and relative to the suture element.

In addition or alternatively, and in a twentieth aspect, a method ofdeploying a heart valve anchor apparatus may further comprise severingthe suture element of the tissue penetrating device proximal of the stopfeature, and applying tension to a portion of the suture element of thetissue penetrating device distal to the second radially expandableportion while applying a proximally-directed force to the distal portionof the body to place the body into a shortened configuration wherein thetissue is compressed between the first radially expandable portion andthe second radially expandable portion.

The above summary of some embodiments, aspects, and/or examples is notintended to describe each embodiment or every implementation of thepresent disclosure. The figures and the detailed description whichfollows more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a partial cut-away view of an example heart;

FIGS. 2-12 illustrate example bodies associated with a heart valveanchor apparatus;

FIGS. 13-13A illustrate an example heart valve anchor apparatus;

FIGS. 14-17 illustrate an example deployment method of the heart valveanchor apparatus of FIGS. 13-13A;

FIGS. 18-18A illustrate an example heart valve anchor apparatus;

FIGS. 19-22 illustrate an example deployment method of the heart valveanchor apparatus of FIGS. 18-18A;

FIGS. 23-23A illustrate an example heart valve anchor apparatus;

FIGS. 24-28 illustrate an example deployment of a heart valve anchorapparatus within a heart valve annulus;

FIGS. 29-30A illustrate example configurations of a heart valve anchorapparatus deployed within a heart valve annulus according to the methodsof FIGS. 14-17 and/or 19-22;

FIG. 31 illustrates an example configuration of a heart valve anchorapparatus within a heart valve annulus;

FIGS. 32-33 illustrate an example deployment of a heart valve anchorapparatus within a heart valve annulus using the configuration of FIG.31;

FIGS. 34-36 illustrate example deployment tools for a heart valve anchorapparatus;

FIG. 37 is a partial cross-sectional schematic view of an example heartvalve anchor apparatus disposed within an example deployment tool in acollapsed or delivery configuration;

FIGS. 38-41 illustrate an example deployment of a heart valve anchorapparatus using an example deployment tool.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosedinvention are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device.

The term “extent” may be understood to mean a greatest measurement of astated or identified dimension. For example, “outer extent” may beunderstood to mean a maximum outer dimension, “radial extent” may beunderstood to mean a maximum radial dimension, “longitudinal extent” maybe understood to mean a maximum longitudinal dimension, etc. Eachinstance of an “extent” may be different (e.g., axial, longitudinal,lateral, radial, circumferential, etc.) and will be apparent to theskilled person from the context of the individual usage. Generally, an“extent” may be considered a greatest possible dimension measuredaccording to the intended usage. In some instances, an “extent” maygenerally be measured orthogonally within a plane and/or cross-section,but may be, as will be apparent from the particular context, measureddifferently—such as, but not limited to, angularly, radially,circumferentially (e.g., along an arc), etc.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent throughout the world. Some mammalian hearts (e.g., human,etc.) include four heart valves: a tricuspid valve 12, a pulmonary valve14, an aortic valve 16, and a mitral valve 18, as seen in an exampleheart 10 illustrated in FIG. 1. The purpose of the heart valves is toallow blood to flow through the heart 10 and from the heart 10 into themajor blood vessels connected to the heart 10, such as the aorta 20 andthe pulmonary artery 22, for example. In a normally functioning heartvalve, blood is permitted to pass or flow downstream through the heartvalve (e.g., from an atrium to a ventricle, from a ventricle to anartery, etc.) when the heart valve is open, and when the heart valve isclosed, blood is prevented from passing or flowing back upstream throughthe heart valve (e.g., from a ventricle to an atrium, etc.). Whenregurgitation occurs, a heart valve fails to open and/or close properlysuch that blood is permitted to pass or flow back upstream through theheart valve (e.g., from a ventricle to an atrium, etc.). In some cases,the defective heart valve may have leaflets that may not close, or maynot be capable of closing, completely. One possible remedy is an annularreduction procedure that may be performed to reduce an overall extent ofthe defective heart valve to bring the heart valve leaflets closertogether, thereby permitting the heart valve leaflets to properly closethe heart valve to the passage of blood.

Disclosed herein are apparatus, medical devices, and/or methods that maybe used to diagnose, treat, and/or repair a portion of thecardiovascular system. At least some of the apparatus, medical devices,and/or methods disclosed herein may include and/or be used to deliverand implant a heart valve anchor. In addition, the apparatus and/ormedical devices disclosed herein may deliver a heart valve anchor usingopen-heart surgical methods or via minimally-invasive intravasculartechniques. The devices and methods disclosed herein may also provide anumber of additional desirable features and/or benefits as described inmore detail below.

An example heart valve anchor apparatus may include a body 100configured and/or adapted to transition between a collapsed or deliveryconfiguration, as illustrated in FIG. 2, and an expanded or unstressedconfiguration, as illustrated in FIGS. 3 and 4. In some embodiments, thebody 100 may be further configured and/or adapted to transition betweenthe unstressed configuration and a shortened configuration, as will bedescribed further below. Other embodiments, aspects, and/or examples maybe described herein, wherein like reference numerals (e.g., 100, 200,300, etc.) refer to similar elements among the various embodiments,aspects, and/or examples. In some embodiments, the body 100 may have aproximal portion 102 proximate a proximal end, and a distal portion 104proximate a distal end.

In some embodiments, the body 100 may comprise a first radiallyexpandable portion 110 at the proximal portion 102 of the body 100, asecond radially expandable portion 120 at the distal portion 104 of thebody 100, and a root portion 130 extending from the first radiallyexpandable portion 110 to the second radially expandable portion 120. Insome embodiments, the first radially expandable portion 110 and/or thesecond radially expandable portion 120 may extend radially outward fromthe root portion 130 in the expanded or unstressed configuration. Insome embodiments, the first radially expandable portion 110 and/or thesecond radially expandable portion 120 may form a bulbous shape, adisc-like shape, a concave shape, a convex shape, and/or combinations ofthese shapes in the expanded or unstressed configuration.

The body 100 may include a stent structure and/or be formed from aplurality of wires. In some embodiments, the plurality of wires may beoriented and/or formed into a braided configuration. In someembodiments, the body 100, including the first radially expandableportion 110, the second radially expandable portion 120, and the rootportion 130 may be unitarily formed. In other words, each of theplurality of wires may extend from the proximal end to the distal endand form a portion of each of the first radially expandable portion 110,the second radially expandable portion 120, and the root portion 130.Other arrangements and configurations are also contemplated. In someembodiments, the plurality of wires may include about 4 wires to about50 wires (e.g., 4, 6, 8, 10, 12, 16, 18, 24, 32 wires, etc.). In someembodiments, the plurality of wires may include wires having a size(e.g., diameter, etc.) of about 0.0127 mm (0.0005 inches) to about 0.127mm (0.005 inches). In some embodiments, the plurality of wires may bemetallic wires, polymeric wires, composite wires, and/or otherbiocompatible materials. Some suitable non-limiting materials for theplurality of wires are described below.

In some embodiments, the body 100 may be tubular and/or may include alumen extending between the proximal end and the distal end of the body100 through the proximal portion 102, the first radially expandableportion 110, the root portion 130, the distal portion 104, and/or thesecond radially expandable portion 120. In some embodiments, the body100 may include a proximal coupler 140 extending from the first radiallyexpandable portion 110 toward and/or to the proximal end. In someembodiments, the body 100 may include a distal coupler 150 extendingfrom the second radially expandable portion 120 toward and/or to thedistal end. In some embodiments, the proximal coupler 140 and/or thedistal coupler 150 may each be a tubular structure disposed about atleast a part of the proximal portion 102 and/or the distal portion 104,respectively. In some embodiments, the proximal coupler 140 and/or thedistal coupler 150 may each be configured to bind the plurality of wirestogether to prevent the stent structure and/or the braided configurationfrom becoming unraveled. In some embodiments, the proximal coupler 140and/or the distal coupler 150 may be fixedly attached (e.g., welded,crimped, etc.) to the proximal end and/or the distal end, respectively,of the body 100. In some embodiments, the body 100 may include an innertubular member disposed within and/or fixedly attached to the pluralityof wires at and/or adjacent to each of the proximal end and the distalend.

In some embodiments, the root portion 130 may be configured to expand orself-expand radially outward between the collapsed or deliveryconfiguration and the expanded or unstressed configuration. In someembodiments, the root portion 130 may have and/or define a maximum outerextent, measured radially or in cross-section for example, in theexpanded or unstressed configuration. In some embodiments, the rootportion 130 may have a length, or a longitudinal distance between thefirst radially expandable portion 110 and the second radially expandableportion 120, of about 3 mm to about 30 mm (e.g., 3, 5, 7, 10, 12, 15,20, 25, 30 mm, etc.). In some embodiments, the maximum outer extentand/or diameter of the root portion 130 may be from about 0.250 mm toabout 30 mm (e.g., 0.250, 0.5, 0.75, 1, 2, 3, 5, 7, 10, 13, 15, 20, 30mm, etc.).

In some embodiments, the first radially expandable portion 110 may beconfigured to be expanded and/or to self-expand to an outer extentgreater than the maximum outer extent of the root portion 130 whenradially unconstrained (e.g., when in the unstressed configuration, theshortened configuration, when not in the delivery configuration, etc.).In some embodiments, the second radially expandable portion 120 may beconfigured to be expanded and/or to self-expand to an outer extentgreater than the maximum outer extent of the root portion 130 whenradially unconstrained (e.g., when in the unstressed configuration). Inat least some embodiments, the first radially expandable portion 110 andthe second radially expandable portion 120 may include and/or be formedhaving a similar or the same outer extent, size, and/or shape. Forexample, in some embodiments, the first radially expandable portion 110and/or the second radially expandable portion 120 may have a generallyround outer shape or profile defining an outer diameter. In someembodiments, the first radially expandable portion 110 and the secondradially expandable portion 120 may have a maximum outer diameter orouter extent of about 2 mm to about 30 mm (e.g., 2, 3, 4, 5, 7, 10, 15,20, 30 mm, etc.). A maximum length of the first radially expandableportion 110 and/or the second radially expandable portion 120 along acentral or longitudinal axis or centerline of the body 100 may be fromabout 0.5 mm to about 15 mm (e.g., 0.5, 1, 2, 4, 5, 7, 8, 10, 15 mm,etc.). Other configurations are also contemplated.

In some embodiments, the body 100 may include and/or define alongitudinal centerline extending between the proximal end and thedistal end of the body 100. In some embodiments, the longitudinalcenterline may be coincident with and/or coaxial with the lumenextending between the proximal end and the distal end of the body 100.In some embodiments, the longitudinal centerline may not necessarily bean axis or a straight line. As shown in FIG. 4, the root portion 130 mayinclude and/or be formed with at least one curve, arc, bend, angle,and/or other non-straight feature along its length. In some embodiments,the at least one curve, arc, bend, angle, and/or other non-straightfeature may extend for the length of the root portion 130. In someembodiments, when the body 100 is in the expanded or unstressedconfiguration, the longitudinal centerline may extend away from a planetangent to the root portion 130. In other words, both opposing ends ofthe longitudinal centerline may extend away from and/or benon-intersecting with the plane tangent to the root portion 130. In someembodiments, the body 100 may have an overall longitudinal length in thecompressed or delivery configuration of about 20 mm to about 80 mm(e.g., 20, 25, 30, 40, 50, 60, 75, 80 mm, etc.). In some embodiments,the body 100 may have an overall longitudinal length in the expanded orunstressed configuration of about 10 mm to about 60 mm (e.g., 10, 15,20, 25, 30, 40, 50, 60 mm, etc.).

In the expanded or unstressed configuration, the first radiallyexpandable portion 110 and/or the second radially expandable portion 120may extend radially outward from the root portion 130. In someembodiments, the first radially expandable portion 110 and/or the secondradially expandable portion 120, and/or a plane through the greatestouter extent of the first and/or second radially expandable portions110, 120, may be arranged at a non-zero angle relative to thelongitudinal centerline. In some embodiments, the first radiallyexpandable portion 110 and/or the second radially expandable portion 120may be substantially perpendicular to the longitudinal centerline. Insome embodiments, the first radially expandable portion 110 and/or thesecond radially expandable portion 120 may be arranged at an obliqueangle to the longitudinal centerline.

In some embodiments, a body 200, 300 may include a generally straightroot portion 230, 330, wherein a proximal portion 202, 302 and a distalportion 204, 304 are arranged at a non-zero angle relative to the rootportion 230, 330, as seen in FIGS. 5 and 6, respectively, for example.The bodies 200, 300 may have and/or include similar characteristicsand/or features to the body 100, which will not all be repeated indetail in the interest of brevity. In FIG. 5, the proximal portion 202and the distal portion 204 are arranged to form a bend or curve ofapproximately 90 degrees relative to the root portion 230. In this case,a first radially expandable portion 210 and a second radially expandableportion 220 may be arranged and/or oriented substantially perpendicularto a longitudinal centerline of the body 200 proximal and distal of thebend or curve, respectively. Other angles and/or arrangements for thefirst radially expandable portion 210 and the second radially expandableportion 220 are also possible. As seen in FIG. 5, the first radiallyexpandable portion 210 and the second radially expandable portion 220may be substantially parallel to the root portion 230. The firstradially expandable portion 210 and the second radially expandableportion 220 may include and/or be formed having a similar or the sameouter extent, size, and/or shape.

In FIG. 6, the proximal portion 302 and the distal portion 304 arearranged to form an oblique bend or curve relative to the root portion330. In some embodiments, the oblique bend or curve may be between 0degrees and 90 degrees, between 20 degrees and 70 degrees, or between 30degrees and 60 degrees relative to the root portion 330. In this case, afirst radially expandable portion 310 and a second radially expandableportion 320 may be arranged and/or oriented substantially perpendicularto a longitudinal centerline of the body 300 proximal and distal of thebend or curve, respectively. Other angles and/or arrangements for thefirst radially expandable portion 310 and the second radially expandableportion 320 are also possible. As seen in FIG. 6, the first radiallyexpandable portion 310 and the second radially expandable portion 320may be arranged at an oblique angle to the root portion 330. The firstradially expandable portion 310 and the second radially expandableportion 320 may include and/or be formed having a similar or the sameouter extent, size, and/or shape.

FIG. 7 illustrates a body 400 having characteristics similar to those ofthe bodies 100-300 which will not all be repeated in detail. As may beseen in FIG. 7, the body 400 may include a first radially expandableportion 410 and a second radially expandable portion 420 having asubstantially straight root portion 430 extending between the firstradially expandable portion 410 and the second radially expandableportion 420. In FIG. 7, the first radially expandable portion 410 andthe second radially expandable portion 420 are arranged substantiallyperpendicular to the root portion 430 and/or a longitudinal centerlineof the body 400. Other angles and/or arrangements for the first radiallyexpandable portion 410 and the second radially expandable portion 420are also possible. As seen in FIG. 7, the first radially expandableportion 410 and the second radially expandable portion 420 may includeand/or be formed having a similar and/or the same outer extent, size,and/or shape, although other configurations are also possible.

FIG. 8 illustrates a body 500 having characteristics similar to those ofthe bodies 100-400 which will not all be repeated in detail. As may beseen in FIG. 8, the body 500 may include a first radially expandableportion 510 and a second radially expandable portion 520 having a rootportion 530 extending between the first radially expandable portion 510and the second radially expandable portion 520. In FIG. 8, the firstradially expandable portion 510 and the second radially expandableportion 520 are arranged substantially perpendicular to the root portion530 and/or a longitudinal centerline of the body 500. Other anglesand/or arrangements for the first radially expandable portion 510 andthe second radially expandable portion 520 are also possible. As seen inFIG. 8, the first radially expandable portion 510 and the secondradially expandable portion 520 may include and/or be formed having adifferent outer extent, size, and/or shape from each other, althoughother configurations are also possible.

FIG. 9 illustrates a body 600 having characteristics similar to those ofthe bodies 100-500 which will not all be repeated in detail. As may beseen in FIG. 9, the body 600 may include a first radially expandableportion 610 and a second radially expandable portion 620 having a rootportion 630 extending between the first radially expandable portion 610and the second radially expandable portion 620. In FIG. 9, the firstradially expandable portion 610 and the second radially expandableportion 620 have a generally bulbous shape extending radially outwardfrom the root portion 630 and are arranged with a maximum outer extentsubstantially perpendicular to the root portion 630 and/or alongitudinal centerline of the body 600. Other angles and/orarrangements for the first radially expandable portion 610 and thesecond radially expandable portion 620 are also possible. In someembodiments, the root portion 630 may include a tubular member disposedover the root portion 630 and/or the root portion 630 may be formed froma tubular member. As seen in FIG. 9, the first radially expandableportion 610 and the second radially expandable portion 620 may includeand/or be formed having a similar or the same outer extent, size, and/orshape, although other configurations are also possible.

FIG. 10 illustrates a body 700 having characteristics similar to thoseof the bodies 100-600 which will not all be repeated in detail. As maybe seen in FIG. 10, the body 700 may include a first radially expandableportion 710 and a second radially expandable portion 720 having a rootportion 730 extending between the first radially expandable portion 710and the second radially expandable portion 720. In FIG. 10, the firstradially expandable portion 710 and/or the second radially expandableportion 720 have a generally convex shape extending radially outwardfrom the root portion 730, as viewed from the proximal end and/or thedistal end of the body 700, respectively, and are arranged with amaximum outer extent substantially perpendicular to the root portion 730and/or a longitudinal centerline of the body 700. In other words, thefirst radially expandable portion 710 and the second radially expandableportion 720 may extend away from the root portion 730 and toward alongitudinal center of the body 700, as viewed from the side of the body700. Other angles and/or arrangements for the first radially expandableportion 710 and the second radially expandable portion 720 are alsopossible. As seen in FIG. 10, the first radially expandable portion 710and the second radially expandable portion 720 may include and/or beformed having a similar or the same outer extent, size, and/or shape,although other configurations are also possible.

FIG. 11 illustrates a body 800 having characteristics similar to thoseof the bodies 100-700 which will not all be repeated in detail. As maybe seen in FIG. 11, the body 800 may include a first radially expandableportion 810 and a second radially expandable portion 820 having a rootportion 830 extending between the first radially expandable portion 810and the second radially expandable portion 820. In FIG. 11, the firstradially expandable portion 810 and/or the second radially expandableportion 820 have a generally concave shape extending radially outwardfrom the root portion 830, as viewed from the proximal end and/or thedistal end of the body 800, respectively, and are arranged with amaximum outer extent substantially perpendicular to the root portion 830and/or a longitudinal centerline of the body 800. In other words, thefirst radially expandable portion 810 and the second radially expandableportion 820 may extend away from the root portion 830 and toward theproximal end and the distal end of the body 800, respectively, as viewedfrom the side of the body 800. Other angles and/or arrangements for thefirst radially expandable portion 810 and the second radially expandableportion 820 are also possible. As seen in FIG. 11, the first radiallyexpandable portion 810 and the second radially expandable portion 820may include and/or be formed having a similar or the same outer extent,size, and/or shape, although other configurations are also possible.

FIG. 12 illustrates a body 900 having characteristics similar to thoseof the bodies 100-800 which will not all be repeated in detail. As maybe seen in FIG. 12, the body 900 may include a first radially expandableportion 910 and a second radially expandable portion 920 having a rootportion 930 extending between the first radially expandable portion 910and the second radially expandable portion 920. In FIG. 12, the firstradially expandable portion 910 and/or the second radially expandableportion 920 have a generally concave shape extending radially outwardfrom the root portion 930, as viewed from the proximal end and/or thedistal end of the body 900, respectively, and an secondary expandableportion disposed on each of the proximal portion and the distal portionof the body 900. The secondary expandable portion may be positionedwithin the concave shape of the first radially expandable portion 910and the second radially expandable portion 920, and/or between the firstradially expandable portion 910 and the second radially expandableportion 920 and the proximal end and the distal end, respectively. Thefirst radially expandable portion 910 and the second radially expandableportion 920 are arranged with a maximum outer extent substantiallyperpendicular to the root portion 930 and/or a longitudinal centerlineof the body 900. In other words, the first radially expandable portion910 and the second radially expandable portion 920 may extend away fromthe root portion 930 and toward the proximal end and the distal end ofthe body 900, respectively, as viewed from the side of the body 900.Other angles and/or arrangements for the first radially expandableportion 910 and the second radially expandable portion 920 are alsopossible. As seen in FIG. 12, the first radially expandable portion 910and the second radially expandable portion 920 may include and/or beformed having a similar or the same outer extent, size, and/or shape,although other configurations are also possible.

As discussed above, FIGS. 2-12 illustrate some aspects of variouspossible configurations of a body of a heart valve anchor apparatus. Itshould be noted that while not explicitly discussed or illustrated, theskilled artisan, in possession of the current disclosure, could easilycombine different aspects and/or features of the various configurationsdiscussed above. Combinations of shapes, sizes, angles, orientations,and/or other defining characteristics of the disclosed bodies orelements thereof are fully contemplated within the scope of thisdisclosure. In order to facilitate understanding, the followingdiscussion may be directed toward the body 100, but it is to beunderstood that any of the above disclosed bodies and/or combinations ofelements thereof may be used in place of the body 100 below with nomodification(s) or minor modification(s) within the capabilities of theskilled person.

FIGS. 13 and 13A illustrate an example heart valve anchor apparatusincluding the body 100 housed at least partially within an exampletissue penetrating device, such as an elongated sheath 1300, in adelivery configuration. In some embodiments, the heart valve anchorapparatus may include a needle 1100, a suture element 1200 having aproximal end 1202 attached to the needle 1100, and an elongated sheath1300 having a deployment head 1310 fixedly attached at a proximal end1302 of the elongated sheath 1300. The elongated sheath 1300 and/or thedeployment head 1310 may include a lumen extending therethrough. Thesuture element 1200 may pass distally into the lumen of the deploymenthead 1310 and may have or include a stop feature 1210 disposed withinthe deployment head 1310. The body 100 may be at least partiallydisposed within the lumen of the elongated sheath 1300 and/or a portionof the body 100 may extend distally from the lumen of the elongatedsheath 1300. The body 100 may have a second suture element 1400extending through the lumen of the body 100 along the longitudinalcenterline. The second suture element 1400 may be separate from and/orindependent of the suture element 1200. In some embodiments, the secondsuture element 1400 may include a first stop feature 1410 disposedproximally of the body 100 within the elongated sheath 1300 and/or thedeployment head 1310, and a second stop feature 1420 disposed distallyof the body 100. In at least some embodiments, the first stop feature1410 and/or the second stop feature 1420 may be disposed proximate theirrespective end of the second suture element 1400. In addition oralternatively, in some embodiments, the body 100 may include firstand/or second stop elements, within or formed from the proximal coupler140 and/or the distal coupler 150 for example, to secure the body 100 tothe second suture element 1400. Translation of the elongated sheath 1300proximally relative to the body 100 may release the body 100 such thatthe body 100 is radially unconstrained and/or free to assume theexpanded or unstressed configuration. In at least some embodiments, inthe delivery configuration, the first radially expandable portion 110 isdisposed within the lumen of the elongated sheath 1300 in the collapsedconfiguration and the second radially expandable portion 120 is disposedoutside of and/or distal of the elongated sheath 1300 in the expandedconfiguration. In other words, when using the body 100 in conjunctionwith the elongated sheath 1300, the delivery configuration may includethe body 100 being in a state of partial expansion wherein the secondradially expandable portion 120 is in the expanded or unstressedconfiguration while the first radially expandable portion 110 is in thecollapsed configuration. In some embodiments, the suture element 1200may be disposed through the proximal end of the deployment head 1310.The stop feature 1210 of the suture element 1200 may be disposedproximal of the first radially expandable portion 110 and/or the body100. In some embodiments, the elongated sheath 1300 may include and/orbe formed from a polymeric material, although other biocompatiblematerials are also contemplated. In some embodiments, the deploymenthead 1310 may include a tapered proximal end and a reduced outerdiameter distal end portion coupled to the elongated sheath 1300. Insome embodiments, the deployment head 1310 may include and/or be formedfrom a metallic material, a polymeric material, a composite material, orother biocompatible materials. In at least some embodiments, thedeployment head 1310 and the elongated sheath 1300 may be formed fromdifferent materials. Some suitable non-limiting materials for theelongated sheath 1300 and/or the deployment head 1310 are describedbelow.

FIGS. 14-17 illustrate different stages of an example “automatic” methodof deploying a heart valve anchor apparatus using the heart valve anchorapparatus and/or the tissue penetrating device of FIGS. 13 and 13A. InFIG. 13, a body 100 is at least partially disposed within the elongatedsheath 1300. The suture element 1200 extends proximally from thedeployment head 1310 to the needle 1100. The needle 1100 may be adaptedand configured to be grasped by a user's hand to guide the needle 1100through tissue and/or to thereafter pull the needle 1100, the sutureelement 1200, the elongated sheath 1300, and/or the body 100 throughand/or into engagement with the tissue. In FIG. 14, the needle 1100 andthe suture element 1200 have been pulled proximally relative to the body100. Pulling the suture element 1200 proximally engages the stop feature1210 against a distally-facing wall at and/or within the proximal end ofthe deployment head 1310. Further proximal translation of the needle1100 and/or the suture element 1200 relative to the body 100 pulls theelongated sheath 1300 proximally relative to the body 100 to partiallyexpose the root portion 130 of the body 100 in addition to the secondradially expandable portion 120. In FIG. 15, the first radiallyexpandable portion 110 has been released from the elongated sheath 1300and has expanded to the expanded or unstressed configuration with thesecond suture element 1400 extending through the body 100. Additionalproximal translation of the needle 1100 and/or the suture element 1200relative to the body 100 then separates the elongated sheath 1300 fromthe body 100. The suture element 1200 remains disposed through thedeployment head 1310 and attached to the needle 1100 while the secondsuture element 1400 extends through the body 100, as seen in FIG. 16 forexample. Upon separating the elongated sheath 1300 from the body 100,the body 100 is completely released from the tissue penetrating device.In some embodiments, the body 100 may then be manually manipulated fromthe expanded or unstressed configuration toward and/or into a shortenedconfiguration, as shown in FIG. 17, by applying tension to a distalportion of the second suture element 1400 while a proximally-directedforce is applied to the distal portion 104 of the body 100 and/or byapplying tension to a proximal portion of the second suture element 1400while a distally-directed force is applied to the proximal portion 102of the body 100. In the shortened configuration, the first radiallyexpandable portion 110 and the second radially expandable portion 120are closer together than in the expanded or unstressed configuration. Insome embodiments, the root portion 130 may be longitudinally compressedand/or shortened in the shortened configuration. In some embodiments, anouter extent of the root portion 130 may expand radially up to or as faras the outer extent of the first radially expandable portion 110 and/orthe second radially expandable portion 120 as the body 100 and/or theroot portion 130 is compressed and/or shortened longitudinally. In otherwords, in some embodiments, a maximum outer extent of the root portion130 may increase as the length of the root portion 130 is decreased. Astop element, within or formed from the proximal coupler 140 and/or thedistal coupler 150 for example, may secure the body 100 to the secondsuture element 1400 and retain the body 100 in the shortenedconfiguration.

FIGS. 18 and 18A illustrate an example heart valve anchor apparatusincluding a body 100 housed at least partially within an example tissuepenetrating device, such as an elongated sheath 1300, in a deliveryconfiguration. In some embodiments, the heart valve anchor apparatus mayinclude a needle 1100, a suture element 1200 having a proximal end 1202attached to the needle 1100, and an elongated sheath 1300 having adeployment head 1310 fixedly attached at a proximal end 1302 of theelongated sheath 1300. The elongated sheath 1300 and/or the deploymenthead 1310 may include a lumen extending therethrough. The suture element1200 may pass distally into the lumen of the deployment head 1310 andmay have or include a stop feature 1210 disposed within the deploymenthead 1310. The body 100 may be at least partially disposed within thelumen of the elongated sheath 1300 and/or a portion of the body 100 mayextend distally from the lumen of the elongated sheath 1300. Translationof the elongated sheath 1300 proximally relative to the body 100 mayrelease the body 100 such that the body 100 is radially unconstrainedand/or free to assume the expanded or unstressed configuration. In atleast some embodiments, in the delivery configuration, the firstradially expandable portion 110 is disposed within the lumen of theelongated sheath 1300 in the collapsed configuration and the secondradially expandable portion 120 is disposed outside of and/or distal ofthe elongated sheath 1300 in the expanded configuration. When using thebody 100 in conjunction with the elongated sheath 1300, the deliveryconfiguration may include the body 100 being in a state of partialexpansion wherein the second radially expandable portion 120 is in theexpanded or unstressed configuration while the first radially expandableportion 110 is in the collapsed configuration. In some embodiments, thesuture element 1200 may be disposed through the body 100 along thelongitudinal centerline. The stop feature 1210 of the suture element1200 may be disposed proximal of the first radially expandable portion110 and/or the body 100. In some embodiments, the suture element 1200may include an additional stop feature 1220 disposed distal of thesecond radially expandable portion 120 and/or the body 100. In someembodiments, the elongated sheath 1300 may include and/or be formed froma polymeric material, although other biocompatible materials are alsocontemplated. In some embodiments, the deployment head 1310 may includea tapered proximal end and a reduced diameter distal end portion coupledto the elongated sheath 1300. In some embodiments, the deployment head1310 may include and/or be formed from a metallic material, a polymericmaterial, a composite material, or other biocompatible materials. Somesuitable non-limiting materials for the elongated sheath 1300 and/or thedeployment head 1310 are described below.

FIGS. 19-22 illustrate different stages of an example “manual” method ofdeploying a heart valve anchor apparatus using the heart valve anchorapparatus and/or the tissue penetrating device of FIGS. 18 and 18A. InFIG. 18, a body 100 is at least partially disposed within the elongatedsheath 1300. The suture element 1200 extends proximally from thedeployment head 1310 to the needle 1100. The needle 1100 may be adaptedand configured to be grasped by a user's hand to guide the needle 1100through tissue and/or to thereafter pull the needle 1100, the sutureelement 1200, the elongated sheath 1300, and/or the body 100 throughand/or into engagement with the tissue. After engaging the secondradially expandable portion 120 against the tissue, the elongated sheath1300 may be pulled proximally relative to the body 100 (and/or thesuture element 1200) by grasping the deployment head 1310 with a forceps1500, as seen in FIG. 19 for example. Further proximal translation ofthe deployment head 1310 and/or the forceps 1500 relative to the body100 and/or the suture element 1200 pulls the elongated sheath 1300proximally relative to the body 100 and/or the suture element 1200 topartially expose the root portion 130 of the body 100 in addition to thesecond radially expandable portion 120. In FIG. 20, the first radiallyexpandable portion 110 has been released from the elongated sheath 1300and has expanded to the expanded or unstressed configuration. Additionalproximal translation of the elongated sheath 1300, the deployment head1310, and/or the forceps 1500 relative to the body 100 and/or the sutureelement 1200 then separates the elongated sheath 1300 from the body 100.The suture element 1200 remains disposed through the body 100 andextends into and through the elongated sheath 1300 to the needle 1100until the suture element 1200 is severed, broken, or cut, as seen inFIG. 21 for example. Upon releasing, severing, breaking, or cutting thesuture element 1200, the body 100 is completely released from the tissuepenetrating device. In some embodiments, the body 100 may then bemanually manipulated from the expanded or unstressed configurationtoward and/or into a shortened configuration, as shown in FIG. 22, byapplying tension to a distal portion of the suture element 1200 while aproximally-directed force is applied to the distal portion 104 of thebody 100 and/or by applying tension to a proximal portion of the sutureelement 1200 while a distally-directed force is applied to the proximalportion 102 of the body 100. In the shortened configuration, the firstradially expandable portion 110 and the second radially expandableportion 120 are closer together than in the expanded or unstressedconfiguration. In some embodiments, the root portion 130 may belongitudinally compressed and/or shortened in the shortenedconfiguration. In some embodiments, an outer extent of the root portion130 may expand radially up to or as far as the outer extent of the firstradially expandable portion 110 and/or the second radially expandableportion 120 as the body 100 and/or the root portion 130 is compressedand/or shortened longitudinally. In other words, in some embodiments, amaximum outer extent of the root portion 130 may increase as the lengthof the root portion 130 is decreased. A stop element, within or formedfrom the proximal coupler 140 and/or the distal coupler 150 for example,may secure the body 100 to the suture element 1200 and retain the body100 in the shortened configuration.

FIGS. 23 and 23A illustrate an example heart valve anchor apparatusincluding a body 100 housed at least partially within an example tissuepenetrating device, such as an elongated sheath 1300, in a deliveryconfiguration, similar to the heart valve anchor apparatus of FIGS. 13and 18. FIGS. 13 and 18, for example, are shown with stop feature 1210,1220, 1410, 1420 comprising a knot in the suture element(s) 1200, 1400.However, other stop features are also contemplated. For example, theheart valve anchor apparatus of FIGS. 23 and 23A makes use ofalternative stop features comprising tubular element(s) 1600 crimpedonto the suture element 1200 and/or the second suture element 1400. Invarious embodiments of a heart valve anchor apparatus, differentembodiments of the stop feature(s) 1210, 1220, 1410, 1420, 1600 may beused and/or interchanged as desired. For example, in some embodiments,one stop feature may be a knot while another stop feature may be atubular element. Other alternatives, configurations, and/or combinationsare also contemplated. The tubular element 1600 may be made from anysuitable biocompatible material. Some examples of suitable materials arediscussed below.

FIGS. 24-28 illustrate example methods of deploying a heart valve anchorapparatus using the heart valve anchor apparatus and/or the tissuepenetrating device of FIGS. 13-23. FIGS. 24-28 apply similarly to thetwo different configurations and/or methods of deploying a heart valveanchor apparatus discussed above. As seen in FIG. 24, a tissuepenetrating device may be directed into tissue 30 of a heart valveannulus (e.g., an annulus of the tricuspid valve 12, the pulmonary valve14, the aortic valve 16, or the mitral valve 18). It is to be noted thatwhile a bicuspid heart valve having two valve leaflets (e.g., the mitralvalve 18, etc.) is illustrated in the figures, the same method may beapplied to a heart valve having three valve leaflets (e.g., thepulmonary valve 14, the tricuspid valve 12, the aortic valve 16, etc.).The method may also be applied from either the upstream side or thedownstream side of the heart valve, depending upon the approach used(e.g., surgical, intravascular, subclavian, aortic, femoral, arterial,venous, etc.). The tissue penetrating device, for example the needle1100, may be directed into the tissue 30 from a first side of the heartvalve annulus, through the tissue 30, and back out the first side of theheart valve annulus, as seen in FIG. 24. In some embodiments, thisprocess may be repeated one or more additional times to pass the tissuepenetrating device through additional tissue 30, thereby forming one ormore plications of tissue. In other words, the tissue penetrating devicemay be zig-zagged through the tissue 30 and/or take a non-linear paththrough the tissue 30 before the body 100 is released and/ortransitioned from the delivery or compressed configuration to theexpanded or unstressed configuration. Additional details related to thepassage and/or path of the heart valve anchor apparatus through thetissue 30 will be discussed below. After the needle 1100 has passedthrough the tissue 30, the needle 1100 and/or the suture element 1200may be pulled proximally away from the tissue 30 as discussed aboveuntil the deployment head 1310 of the elongated sheath 1300 engages thetissue 30, as seen in FIG. 25. Proximal translation of the needle 1100and/or the suture element 1200 may pull the deployment head 1310 and/orthe elongated sheath 1300 through the tissue 30 and engage the secondradially expandable portion 120 of the body 100 against the tissue 30 ofthe heart valve annulus. From this point, the deployment head 1310 ofthe elongated sheath 1300 is pulled away (e.g., translated proximallyrelative to the body 100) from the second radially expandable portion120 using one of the methods described above, thereby releasing the rootportion 130 within the tissue 30, as seen in FIG. 26, and the firstradially expandable portion 110 outside of the tissue 30, as seen inFIG. 27, such that the first radially expandable portion 110 and thesecond radially expandable portion 120 both engage the tissue 30disposed between them in the unstressed configuration. In someembodiments, the suture element 1200 (if still present, depending on themethod of deployment used) may be severed, broken, or cut to release thebody 100. In some embodiments, the body 100 may be transitioned from theexpanded or unstressed configuration toward and/or to the shortenedconfiguration, as shown in FIG. 28 for example, in one of the methods orsteps described above. In the unstressed and/or shortened configuration,the tissue 30 may be compressed between the first radially expandableportion 110 and the second radially expandable portion 120.

In any given method or application of the heart valve anchor apparatus,at least one heart valve anchor apparatus may be deployed within a heartvalve annulus. In some example, the at least one heart valve anchorapparatus may include two, three, four, or more heart valve anchorapparatus deployed within the heart valve annulus as necessary tosufficiently reduce, tighten, and/or contract the heart valve annulus tobring the free edges of the heart valve leaflets back into appositionwhen the heart valve is closed. In some embodiments, at least one heartvalve anchor apparatus may be deployed within or adjacent the annulus ofone, more than one, or each cusp or leaflet of the heart valve beingtreated. It has been found that the body of the heart valve anchorapparatus may sufficiently influence the tissue of the heart valveannulus to resolve heart valve regurgitation in the expanded orunstressed configuration, or the body of the heart valve anchorapparatus may be transitioned to the shortened configuration whenadditional influence is needed to resolve heart valve regurgitation.

FIG. 29 illustrates an example passage and/or method of a tissuepenetrating device through the tissue 30 of the heart valve annulus. Forconvenience, the configuration of FIG. 29 may be referred to as the“tunneling” method. In the “tunneling” method, the heart valve anchorapparatus may be passed into the tissue 30 from a first side of theheart valve annulus, extend generally laterally within the tissue 30 ofthe heart valve annulus without passing completely through a secondopposing side of the heart valve annulus (e.g., the root portion 130 ofthe heart valve anchor apparatus remains within the “wall” or“thickness” of the tissue 30 of the heart valve annulus), and then theheart valve anchor apparatus is passed back through to the first side ofthe heart valve annulus, thereby forming a “tunnel” through the tissue30 which has opposing ends both opening to the same (e.g., first) sideof the heart valve annulus. In the “tunneling” method, both the firstradially expandable portion 110 and the second radially expandableportion 120 engage the tissue 30 on the first side of the heart valveannulus.

FIG. 29A illustrates an example passage and/or method of a tissuepenetrating device through the tissue 30 of the heart valve annulus.FIG. 29A illustrates the same “tunneling” method shown in FIG. 29,wherein the tissue penetrating device has been passed through the tissue30 multiple times (e.g., zig-zagged or forming a non-linear path throughthe tissue 30), thereby forming one or more plications of tissue 30formed between the first radially expandable portion 110 and the secondradially expandable portion 120.

FIG. 30 illustrates another example passage and/or method of a tissuepenetrating device through the tissue 30 of the heart valve annulus. Forconvenience, the configuration of FIG. 30 may be referred to as the “U”method. In the “U” method, the heart valve anchor apparatus may bepassed into the tissue 30 from a first side of the heart valve annulus,extend generally through the tissue 30 of the heart valve annulus andpassing completely through a second opposing side of the heart valveannulus (e.g., the root portion 130 of the heart valve anchor apparatuspasses through the “wall” or “thickness” of the tissue 30 of the heartvalve annulus), the heart valve anchor apparatus is passed generallylaterally alongside the second opposing side of the heart valve annulus,and then the heart valve anchor apparatus is passed back into the tissue30 from the second side of the heart valve annulus, extending generallythrough the tissue 30 of the heart valve annulus and passing completelythrough back to the first side of the heart valve annulus, therebyforming two passages through the tissue 30 which each have opposing endsopening on different sides of the heart valve annulus. In the “U”method, both the first radially expandable portion 110 and the secondradially expandable portion 120 engage the tissue 30 on the first sideof the heart valve annulus. In the “U” method, the root portion 130passes through the tissue 30 from the first side of the heart valveannulus to the second side of the heart valve annulus, extends laterallyalongside the tissue 30 proximate the second side of the heart valveannulus, and passes back through the tissue 30 from the second side ofthe heart valve annulus to the first side of the heart valve annulus. Inthis example, each heart valve anchor apparatus passes completelythrough the tissue 30 in two different locations.

FIG. 30A illustrates an example passage and/or method of a tissuepenetrating device through the tissue 30 of the heart valve annulus.FIG. 30A illustrates the same “U” method shown in FIG. 30, wherein thetissue penetrating device has been passed through the tissue 30 multipletimes (e.g., zig-zagged or forming a non-linear path through the tissue30), thereby forming one or more plications of tissue 30 formed betweenthe first radially expandable portion 110 and the second radiallyexpandable portion 120.

FIG. 31 illustrates another example passage and/or method of a heartvalve anchor apparatus disposed within the tissue 30 of the heart valveannulus. For convenience, the configuration of FIG. 31 may be referredto as the “trans-annular” method. In the “trans-annular” method, theheart valve anchor apparatus may be passed into the tissue 30 from afirst side of the heart valve annulus, extend generally through thetissue 30 of the heart valve annulus, and pass completely through to asecond opposing side of the heart valve annulus (e.g., the root portion130 of the heart valve anchor apparatus passes through the “wall” or“thickness” of the tissue 30 of the heart valve annulus), therebyforming a single passage through the tissue 30 which has opposing endsopening on different sides of the heart valve annulus. In this example,each heart valve anchor apparatus passes completely through the tissue30 at one location. In the “trans-annular” method, the first radiallyexpandable portion 110 and the second radially expandable portion 120engage the tissue 30 on opposite sides of the heart valve annulus. Inother words, the first radially expandable portion 110 may engage thetissue 30 on the first side of the heart valve annulus and the secondradially expandable portion 120 may engage the tissue 30 on the secondside of the heart valve annulus. In practice, the “trans-annular” methodmay sometimes (although it is not required to) utilize pairs of heartvalve anchor apparatus and/or bodies 100. For example, as seen in FIGS.32 and 33, at least one pair 50 of bodies 100 may be disposed withinand/or through the tissue 30 of the heart valve annulus. Each one of thebodies 100 of the pair 50 may include a suture element 54 extendingthrough the body 100. After deploying each one of the bodies 100 of thepair 50, the suture element(s) 54 extending from each body 100 may befastened (e.g., tied, glued, melted, etc.) together to draw the pair 50of bodies 100 closer together, thereby reducing, tightening, and/orcontracting the heart valve annulus to bring the free edges of the heartvalve leaflets back into apposition when the heart valve is closed.

FIGS. 34-36 illustrate example tissue penetrating devices, which mayinclude various configurations of a delivery tool 2000. It is to beunderstood that these configurations are merely exemplary, and otherconfigurations are also contemplated. The skilled person will recognizethat variation of these configurations, as well as differentconfigurations, may also be used with the apparatus of the currentdisclosure.

The delivery tool 2000 of FIG. 34 may include a handle 2100 having a“cigar cutter” configuration. In some embodiments, the handle 2100 mayinclude a hollow, tubular needle 2110 extending distally therefrom. Aheart valve anchor apparatus may include a body 100 (not shown) disposedwithin the needle 2110 in a delivery configuration. In some embodiments,a tubular member may extend between and/or connect the handle 2100 andthe needle 2110. A push rod 2120 may extend proximally from the body 100within the needle 2110 and/or the handle 2100. The push rod 2120 mayconnect and/or be fixedly attached to a movable actuator element 2130.The actuator element 2130 may be axially and/or longitudinally slidablerelative to a body of the handle 2100. The actuator element 2130 may beconfigured and/or adapted to permit a user to actuate the handle 2100with one hand. Axial translation of the actuator element 2130 may resultin corresponding axial translation of the push rod 2120 within theneedle 2110. Distal axial translation of the actuator element 2130and/or the push rod 2120 may release the body 100 from the distal end ofthe needle 2110. In at least some embodiments, the handle 2100 mayaccommodate the suture element 1200 (not shown) extending therethroughfrom the body 100.

The delivery tool 2000 of FIG. 35 may include a handle 2200 having a“pen” configuration. In some embodiments, the handle 2200 may include ahollow, tubular needle 2210 extending distally therefrom. A heart valveanchor apparatus may include a body 100 (not shown) disposed within theneedle 2210 in a delivery configuration. In some embodiments, a tubularmember may extend between and/or connect the handle 2200 and the needle2210. A push rod 2220 may extend proximally from the body 100 within theneedle 2210 and/or the handle 2200. The push rod 2220 may connect and/orbe fixedly attached to a movable actuator element 2230. The actuatorelement 2230 may be axially and/or longitudinally slidable relative to abody of the handle 2200. In some embodiments, the actuator element 2230may be configured and/or adapted to permit a user to actuate the handle2200 with one hand. In some embodiments, the actuator element 2230 maybe configured and/or adapted to permit a user to actuate the handle 2200with two hands. Axial translation of the actuator element 2230 mayresult in corresponding axial translation of the push rod 2220 withinthe needle 2210. Distal axial translation of the actuator element 2230and/or the push rod 2220 may release the body 100 from the distal end ofthe needle 2210. In at least some embodiments, the handle 2200 mayaccommodate the suture element 1200 extending therethrough from the body100.

The delivery tool 2000 of FIG. 36 may include a handle 2300 having a“syringe” configuration. In some embodiments, the handle 2300 mayinclude a hollow, tubular needle 2310 extending distally therefrom. Aheart valve anchor apparatus may include a body 100 (not shown) disposedwithin the needle 2310 in a delivery configuration. In some embodiments,a tubular member may extend between and/or connect the handle 2300 andthe needle 2310. A push rod 2320 may extend proximally from the body 100within the needle 2310 and/or the handle 2300. The push rod 2320 mayconnect and/or be fixedly attached to a movable actuator element 2330.The actuator element 2330 may be axially and/or longitudinally slidablerelative to a body of the handle 2300. In some embodiments, the actuatorelement 2330 may be configured and/or adapted to permit a user toactuate the handle 2300 with one hand. In some embodiments, the actuatorelement 2330 may be configured and/or adapted to permit a user toactuate the handle 2300 with two hands. Axial translation of theactuator element 2330 may result in corresponding axial translation ofthe push rod 2320 within the needle 2310. Distal axial translation ofthe actuator element 2330 and/or the push rod 2320 may release the body100 from the distal end of the needle 2310. In at least someembodiments, the handle 2300 may accommodate the suture element 1200(not shown) extending therethrough from the body 100.

FIG. 37 is a partial cross-sectional schematic view of an exampledelivery tool 2000 having a body 100 disposed within a needle 2010 in adelivery configuration. Similar to the delivery tools discussed above, apush rod 2020 may be slidably disposed within the needle 2010 and extendproximally into a body of a handle of the delivery tool 2000 to anactuator element. It will be appreciated that any of the above-describeddelivery tools 2000 may permit and/or utilize this arrangement for thedelivery of the body 100 of a heart valve anchor apparatus.

FIGS. 38-41 illustrate an example method of deploying a body 100 of aheart valve anchor apparatus using the tissue penetrating device(s)and/or the delivery tool(s) 2000 of FIGS. 34-37. As seen in FIG. 38, atissue penetrating device such as a delivery tool 2000 (the handle 2300of FIG. 36 is shown for illustration, but any of the delivery tools 2000may be used) may be directed into tissue 30 of a heart valve annulus(e.g., an annulus of the tricuspid valve 12, the pulmonary valve 14, theaortic valve 16, or the mitral valve 18). It is to be noted that while abicuspid heart valve having two valve leaflets (e.g., the mitral valve18, etc.) is illustrated in the figures, the same method may be appliedto a heart valve having three valve leaflets (e.g., the pulmonary valve14, the tricuspid valve 12, the aortic valve 16, etc.). The method mayalso be applied from either the upstream side or the downstream side ofthe heart valve, depending upon the approach used (e.g., surgical,intravascular, subclavian, aortic, femoral, arterial, venous, etc.). Thetissue penetrating device, for example the delivery tool 2000 and/or theneedle 2010, may be directed into the tissue 30 from a first side of theheart valve annulus, through the tissue 30, and back out the first sideof the heart valve annulus, as seen in FIG. 38. Additional detailsrelated to the passage and/or path of the heart valve anchor apparatusthrough the tissue 30 have been discussed previously with respect toFIGS. 29-31. After the needle 2010 has passed through the tissue 30, theactuator element 2030 and/or the push rod disposed within the deliverytool 2000 may be axially translated distally to begin releasing the body100 out of the needle 2010. While the needle 2010 is positioned with itsdistal end protruding from (e.g., the first side or the second side ofthe heart valve annulus, depending on the method and/or approach used)the tissue 30, the second radially expandable portion 120 may be pushedout of the needle 2010, where it expands to the expanded or unstressedconfiguration, as seen in FIG. 39 for example. The needle 2010 and/orthe handle of the delivery tool 2000 may be pulled proximally backthrough from the tissue 30 as discussed above until the second radiallyexpandable portion 120 engages the tissue 30. Further proximaltranslation of the delivery tool 2000 and/or the needle 2010 may becombined with additional axial translation of the actuator element 2030,and/or the push rod, to release the root portion 130 of the body 100from the delivery tool 2000 and/or the needle 2010 within the tissue 30.From this point, the delivery tool 2000 and/or the needle 2010 is pulledaway from (e.g., translated proximally relative to) the second radiallyexpandable portion 120, thereby releasing the first radially expandableportion 110 outside of the tissue 30, as seen in FIG. 40, such that thefirst radially expandable portion 110 and the second radially expandableportion 120 both engage the tissue 30 disposed between them in theunstressed configuration. In some embodiments, the suture element 1200(if present) may be severed, broken, or cut to release the body 100. Insome embodiments, the body 100 may be transitioned from the expanded orunstressed configuration toward and/or to the shortened configuration,as shown in FIG. 41 for example, in one of the methods or stepsdescribed above. In the shortened configuration, the tissue 30 may becompressed between the first radially expandable portion 110 and thesecond radially expandable portion 120.

In any given method or application of the heart valve anchor apparatus,at least one heart valve anchor apparatus may be deployed within a heartvalve annulus. In some example, the at least one heart valve anchorapparatus may include two, three, four, or more heart valve anchorapparatus deployed within the heart valve annulus as necessary tosufficiently reduce, tighten, and/or contract the heart valve annulus tobring the free edges of the heart valve leaflets back into appositionwhen the heart valve is closed. In some embodiments, at least one heartvalve anchor apparatus may be deployed within or adjacent the annulus ofone, more than one, or each cusp or leaflet of the heart valve beingtreated. It has been found that the body of the heart valve anchorapparatus may sufficiently influence the tissue of the heart valveannulus to resolve heart valve regurgitation in the expanded orunstressed configuration, or the body of the heart valve anchorapparatus may be transitioned to the shortened configuration whenadditional influence is needed to resolve heart valve regurgitation.

In some embodiments, a seal member may be circumferentially disposed onand/or about a portion of the body 100, and as the term suggests, mayhelp to seal an exterior of the body 100 within and/or against thetissue 30 upon deployment (e.g., in the expanded, unstressed, and/orshortened configurations), thereby preventing leakage around the body100. In some embodiments, the seal member may be disposed about, on,and/or radially outward of an outside surface of the body 100, includingone or more of the first radially expandable portion 110, the secondradially expandable portion 120, and/or the root portion 130.Additionally, the lumen extending through the body 100 may include aseal member disposed in the lumen and/or at the proximal and/or distalends of the lumen, to prevent leakage through the body 100. In someembodiments, the seal member(s) may be formed from a polymeric materialor other suitable biocompatible material. In some embodiments, the sealmember(s) may be added or applied to the body 100 using one or moresuitable techniques, such as but not limited to, mechanical attachment,adhesives, coating, electro-spinning, etc. In some embodiments, the sealmember(s) may be configured to fold, pleat, compress, expand outward, orotherwise change shape as the body 100 changes configuration.

The materials that can be used for the various components of the body100-900, the tissue penetrating device, the elongated sheath 1300, thedelivery tool(s) 2000, etc. (and/or other systems disclosed herein) andthe various elements thereof disclosed herein may include those commonlyassociated with medical devices. For simplicity purposes, the followingdiscussion makes reference to the body 100-900, the tissue penetratingdevice, the elongated sheath 1300, the delivery tool(s) 2000, etc.However, this is not intended to limit the devices and methods describedherein, as the discussion may be applied to other elements, members,components, or devices disclosed herein, such as, but not limited to,the body 100-900, the tissue penetrating device, the elongated sheath1300, the delivery tool(s) 2000, etc. and/or elements or componentsthereof.

In some embodiments, the body 100-900, the tissue penetrating device,the elongated sheath 1300, the delivery tool(s) 2000, etc., and/orcomponents thereof (such as, but not limited to, the deployment head1310, the needle 1100, etc.), may be made from a metal, metal alloy,polymer (some examples of which are disclosed below), a metal-polymercomposite, ceramics, combinations thereof, and the like, or othersuitable material. Some examples of suitable metals and metal alloysinclude stainless steel, such as 444V, 444L, and 314LV stainless steel;mild steel; nickel-titanium alloy such as linear-elastic and/orsuper-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the body 100-900, thetissue penetrating device, the elongated sheath 1300, the deliverytool(s) 2000, etc., and/or components thereof, may also be doped with,made of, or otherwise include a radiopaque material. Radiopaquematerials are understood to be materials capable of producing arelatively bright image on a fluoroscopy screen or another imagingtechnique during a medical procedure. This relatively bright image aidsa user in determining the location of the body 100-900, the tissuepenetrating device, the elongated sheath 1300, the delivery tool(s)2000, etc. Some examples of radiopaque materials can include, but arenot limited to, gold, platinum, palladium, tantalum, tungsten alloy,polymer material loaded with a radiopaque filler, and the like.Additionally, other radiopaque marker bands and/or coils may also beincorporated into the design of the body 100-900, the tissue penetratingdevice, the elongated sheath 1300, the delivery tool(s) 2000, etc. toachieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the body 100-900, the tissue penetratingdevice, the elongated sheath 1300, the delivery tool(s) 2000, etc. Forexample, the body 100-900, the tissue penetrating device, the elongatedsheath 1300, the delivery tool(s) 2000, etc., and/or components orportions thereof, may be made of a material that does not substantiallydistort the image and create substantial artifacts (e.g., gaps in theimage). Certain ferromagnetic materials, for example, may not besuitable because they may create artifacts in an MRI image. The body100-900, the tissue penetrating device, the elongated sheath 1300, thedelivery tool(s) 2000, etc., or portions thereof, may also be made froma material that the MRI machine can image. Some materials that exhibitthese characteristics include, for example, tungsten,cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.,UNS: R44035 such as MP35-N® and the like), nitinol, and the like, andothers.

In some embodiments, the body 100-900, the tissue penetrating device,the elongated sheath 1300, the delivery tool(s) 2000, etc., and/orportions thereof, may be made from or include a polymer or othersuitable material. Some examples of suitable polymers may includepolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the body 100-900 may include a fabric materialdisposed over or within the stent structure and/or the plurality ofwires. The fabric material may be composed of a biocompatible material,such a polymeric material or biomaterial, adapted to promote tissueingrowth. In some embodiments, the fabric material may include abioabsorbable material. Some examples of suitable fabric materialsinclude, but are not limited to, polyethylene glycol (PEG), nylon,polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as apolyethylene, a polypropylene, polyester, polyurethane, and/or blends orcombinations thereof.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A heart valve anchor apparatus, comprising: abody having a proximal portion, a proximal end, a distal portion, and adistal end, the body having a delivery configuration, an unstressedconfiguration, and a shortened configuration, the body comprising: afirst radially expandable portion at the proximal portion of the body; asecond radially expandable portion at the distal portion of the body;and a root portion extending from the first radially expandable portionto the second radially expandable portion, the root portion having anouter extent; wherein the first radially expandable portion isconfigured to self-expand to an outer extent greater than the outerextent of the root portion when radially unconstrained; wherein thesecond radially expandable portion is configured to self-expand to anouter extent greater than the outer extent of the root portion whenradially unconstrained; wherein in the unstressed configuration, thebody defines a longitudinal centerline that extends away from a planetangent to the root portion, wherein the body is adapted to be housed atleast partially within a tissue penetrating device in the deliveryconfiguration, wherein the heart valve anchor apparatus further includesa suture element extending longitudinally through the body to a stopfeature disposed opposite a push rod, wherein placing the suture elementin tension while applying an opposing force to the body with the pushrod places the body into a shortened configuration wherein tissue iscompressed between the first radially expandable portion and the secondradially expandable portion.
 2. The heart valve anchor apparatus ofclaim 1, wherein the body is adapted to engage tissue between theproximal portion and the distal portion in the unstressed configurationand the shortened configuration, such that one or more plications oftissue are formed between the proximal portion and the distal portion.3. The heart valve anchor apparatus of claim 2, wherein the body isadapted to compress tissue between the proximal portion and the distalportion in the shortened configuration.
 4. The heart valve anchorapparatus of claim 2, wherein the root portion is adapted to passthrough tissue disposed between the proximal portion and the distalportion.
 5. The heart valve anchor apparatus of claim 1, wherein thebody has an overall length in the unstressed configuration and theoverall length is reduced when the body is in the shortenedconfiguration.
 6. The heart valve anchor apparatus of claim 1, furthercomprising a suture element disposed through the body along thelongitudinal centerline.
 7. The heart valve anchor apparatus of claim 1,further comprising: a needle; a suture element having a proximal endattached to the needle; and an elongated sheath having a deployment headfixedly attached at a proximal end of the elongated sheath, the sutureelement passing distally into the deployment head and having a stopfeature disposed within the deployment head; wherein the body isdisposed at least partially within the elongated sheath.
 8. The heartvalve anchor apparatus of claim 7, wherein translation of the elongatedsheath proximally relative to the body releases the body such that thebody is free to assume the unstressed configuration.
 9. The heart valveanchor apparatus of claim 7, wherein in the delivery configuration, thefirst radially expandable portion is disposed within the elongatedsheath and the second radially expandable portion is disposed distal ofthe elongated sheath.
 10. The heart valve anchor apparatus of claim 7,wherein the stop feature is disposed proximal of the first radiallyexpandable portion.
 11. The heart valve anchor apparatus of claim 1,further comprising: a tissue penetrating device including a lumenextending longitudinally therethrough, the body being disposed withinthe lumen in the delivery configuration; and the push rod disposedwithin the lumen adjacent to the body; wherein translation of the pushrod relative to the tissue penetrating device releases the body from thelumen; wherein after release from the lumen, the body is free to assumethe unstressed configuration.